01 1Natco Pharma
02 1ORGANICA Feinchemie GmbH Wolfen
03 1Olon S.p.A
04 1Trifarma
01 1BENZHEXOL HCL. (TRIHEXYPHENIDYL HCL.)
02 1TRIHEXIPHENIDYL HYDROCHLORIDE
03 1TRIHEXYPHENIDYL HCL
04 1TRIHEXYPHENIDYL HYDROCHLORIDE
01 1Germany
02 1India
03 2Italy
01 2Active
02 2Inactive
01 4Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 22576
Submission : 2009-02-26
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 2693
Submission : 1976-06-16
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 2785
Submission : 1976-11-05
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 5802
Submission : 1985-02-27
Status : Inactive
Type : II
13
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A EINECS 200-142-5 manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of EINECS 200-142-5, including repackagers and relabelers. The FDA regulates EINECS 200-142-5 manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. EINECS 200-142-5 API Manufacturers are required to adhere to Good Manufacturing Practices (GMP) to ensure that their products are consistently manufactured to meet established quality criteria.
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A EINECS 200-142-5 supplier is an individual or a company that provides EINECS 200-142-5 active pharmaceutical ingredient (API) or EINECS 200-142-5 finished formulations upon request. The EINECS 200-142-5 suppliers may include EINECS 200-142-5 API manufacturers, exporters, distributors and traders.
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A EINECS 200-142-5 DMF (Drug Master File) is a document detailing the whole manufacturing process of EINECS 200-142-5 active pharmaceutical ingredient (API) in detail. Different forms of EINECS 200-142-5 DMFs exist exist since differing nations have different regulations, such as EINECS 200-142-5 USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A EINECS 200-142-5 DMF submitted to regulatory agencies in the US is known as a USDMF. EINECS 200-142-5 USDMF includes data on EINECS 200-142-5's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The EINECS 200-142-5 USDMF is kept confidential to protect the manufacturer’s intellectual property.
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